Dura repair with DuraMatrix‑Onlay Plus collagen patch
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
This will try DuraMatrix‑Onlay Plus, a collagen patch, to seal and repair the dura in patients who need a dura substitute during neurosurgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Collagen Matrix Industry-sponsored |
| Locations | 2 sites (Augusta, Georgia and 1 other locations) |
| Trial ID | NCT06802133 on ClinicalTrials.gov |
What this trial studies
This is a prospective, post‑market, open‑label observational project at up to eight sites enrolling about 118 subjects who require a dura substitute. Participants will receive DuraMatrix‑Onlay Plus at the time of surgery and be followed for adverse events and the need for revision surgery, with at least one follow‑up around eight weeks to match the device resorption period where possible. The primary endpoint is the rate of revision surgery, and safety outcomes such as CSF leak, infection, and pseudomeningocele will be recorded at each visit. No original patient records or personally identifying information will be disclosed to the sponsor.
Who should consider this trial
Good fit: Patients who require a dura substitute for repair of the dura mater during neurosurgical procedures and who meet the device's instructions for use are eligible.
Not a fit: Patients with conditions listed as contraindications in the device's instructions for use or those who do not require a dura substitute are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could reduce the need for revision surgery and lower rates of CSF leak after dura repair.
How similar studies have performed: Collagen‑based dural substitutes have been used in clinical practice and prior reports have shown reduced CSF leak rates in some settings, though results vary by product and indication.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The general population will be included in the study where a dura substitute is required for the repair of dura mater. Exclusion Criteria: * Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Where this trial is running
Augusta, Georgia and 1 other locations
- Augusta University — Augusta, Georgia, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Meenakshi Paliwal
- Email: mpaliwal@regenity.com
- Phone: 2014051477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.